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About UserWise:

Our mission is simple…to SAVE LIVES lost to preventable medical errors. Every year there are over 210,000 preventable medical errors which lead to death. Our goal is to do everything in our power to reduce this number significantly. Following global regulations and best practices, we do this by conducting usability studies for testing of medical products.

At UserWise, we co-create safe and usable medical products with our clients. In our studies, we recruit real-life people and observe them simulating the use of medical products to reveal ways to improve these products for our clients.

UserWise is an industry leader in Human Factors Engineering for medical products headquartered in San Jose, California, and with sites also in Boston, Ohio, and Washington. We are looking for someone who wants to make a significant impact in the medical field to not only prevent deaths but also to improve patient care worldwide.

User wise is a subsidiary of ClariMed Inc.:

“The premiere, human centered development and regulatory practice for medical products, point of care devices, companion and combination products, and SaMD.”

ClariMed was formed with the vision that a unique market opportunity exists to build the leader in human centered regulatory and development services for medical products. We believe that a focus on placing human factors at the core of device development and regulatory pathways translates to a “quality by design” approach that drives outsized value for patients, customers, and shareholders. We also believe that a stronger calibration to risk/benefit is emerging and will continue to be a driver of market clearance and reimbursement, which in turn will lead to clients that place an emphasis on “smarter” development.

Position Summary:

As a full-time Human Factors Engineering Manager at UserWise, you will be empowering human factors engineers to consult innovative companies to design safe and usable medical devices, ensuring that user experience is incorporated early and often in the design process. At UserWise, we pride ourselves on being experts and having experience in a variety of products including wearable sensors, surgical devices, diagnostic equipment, drug administration devices, and home-use devices. UserWise is a small company that emphasizes work-life balance. We are located at 919 The Alameda, San Jose, California.

Roles and Responsibilities:

• Managing resource allocation for all UserWise projects
• Analyze available resources.
• Matching the background and training of specific consultants with specific projects.
• Having technical discussions with team members to agree on project scope and delivery schedules, tracking schedules, and related dependencies.
• Manage more than 5 human factors engineers and interns, including:
• Overseeing employee onboarding and training.
• Promoting professional development and mentoring employees.
• Promoting employee engagement and alignment between working goals and each person’s personal aspirations.
• Providing regular feedback to facilitate personal growth.
• Manage operations to key delivery metrics.
• Utilization
• Net Promoter Score
• Project Budget Adherence
• Forecasting
• Write performance reviews and solve internal issues.
• Provide timely feedback related to performance.
• Assist with establishment of annual goals and ensuring employees have opportunity to meet goals.
• Collaborating on distribution of the bonus pool and determining promotions and merit increases.
• Overseeing Hiring (working with the Human Resources department)
• Hire, train, and mentor other engineers and supporting staff.
• Hire and manage contractors.
• As appropriate, review, approve, or modify project work.
• Check the technical accuracy of work.
• Driving quality improvement initiatives and engineering processes.
• Promote positive relationships and professional rapport with UserWise’s Clients.
• Provide expert consultations for clients and UserWise staff, as needed, on applicable guidance’s, standards, regulations, and regulatory expectations related to Human Factors and Usability Engineering for medical products.
• Attend sales meetings and lead direct reports to prepare proposals.
• Support UserWise promotion and presence as an industry thought leader (e.g. presenting at conferences, supporting standard development).
• Develop both internal and external training.
• In collaboration with other SME’s perform a final review of work product before sending deliverables to clients.

Candidate Requirements:

• M.A./M.S. in Engineering preferred. B.A./B.S. in Engineering also acceptable.
• Experience with resource allocation and tracking, preferably in the engineering services/consulting space.
• At least 5 years of experience in medical device, or similarly regulated, industry.
• Exposure to Human Factors Engineering, and experience in a tangential field such as R&D, clinical testing, or user-experience design.
• Strong understanding of medical device product design and regulatory processes
• Experience working within a quality system, preferably at a fortune 500 medical device or pharmaceutical company.
• Ability to collect and synthesize large quantities of information across the broader team into usable communications (i.e., protocols, reports, operating procedures)
• Excellent technical problem solving and interpersonal skills that result in clear verbal communication and presentation skills.
• Experience working with a wide variety of population demographic is desired.
• Ability to work on-site in San Jose, California.